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NCT00680069 · ClinicalTrials.gov registry record · Phase 1
H5N1 (Clade 2) Vaccination of Adults and Elderly
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 517
- Enrollment target
- 8
- Study locations
NCT00680069: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00680069 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 517 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00680069, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 517 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.
Conditions Studied
Interventions
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
Study Locations (8)
California
- Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases - Stanford
Iowa
- University of Iowa - Vaccine Research and Education Unit - Iowa City
Maryland
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore - Baltimore
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
North Carolina
- Duke Translational Medicine Institute - Clinical Vaccine Unit - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Infectious Diseases - Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
What the finished NCT00680069 record still lists
NCT00680069 is an interventional study that assigns participants to a tested intervention. The registered 517 participants enrollment target is mid-sized for trials with a published cap, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 is the first listed.
NCT00680069 lists 8 locations in 8 states (California, Iowa, Maryland).
Frequently Asked Questions
What is clinical trial NCT00680069 about?
NCT00680069 is a clinical study titled "H5N1 (Clade 2) Vaccination of Adults and Elderly". The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is ...
What is the current status of trial NCT00680069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 517 participants. The study started on 2008-11. Estimated completion is 2009-11.
What conditions does trial NCT00680069 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00680069?
The interventions under investigation include: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00680069?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00680069 being conducted?
This trial has 8 study locations across California, Iowa, Maryland, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00680069's enrollment target sits among peer trials
517 50th of 156 higher than 107 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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